A Pragmatic Randomized Controlled Trial of Chinese Herbal Medicine for Severe Pandemic H1N1 Influenza (200907001-2A)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Beijing Ditan Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Beijing University of Chinese Medicine
State Administration of Traditional Chinese Medicine of the People's Republic of China
China Academy of Chinese Medical Sciences
Information provided by:
Beijing Ditan Hospital
ClinicalTrials.gov Identifier:
NCT01053533
First received: January 19, 2010
Last updated: June 7, 2010
Last verified: January 2010
  Purpose

The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe pandemic H1N1 influenza.


Condition Intervention
Influenza A Virus, H1N1 Subtype
Drug: Chinese herbal medicines plus western therapy
Drug: western therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Beijing Ditan Hospital:

Primary Outcome Measures:
  • incidence of complication [ Time Frame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients. ] [ Designated as safety issue: No ]
  • mortality of pandemic H1N1 influenza and all-cause mortality(only for severe pandemic H1N1 influenza patients) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • proportion of deteriorating into severe H1N1 influenza (only for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza) [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to allaying a fever [ Time Frame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients ] [ Designated as safety issue: No ]
  • time to symptom relief [ Time Frame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients ] [ Designated as safety issue: No ]
  • time and proportion of H1N1 virus turning to negative [ Time Frame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients ] [ Designated as safety issue: No ]
  • direct medical cost [ Time Frame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients ] [ Designated as safety issue: No ]
  • safety outcome(adverse effects) [ Time Frame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients ] [ Designated as safety issue: Yes ]
  • days in hospital [ Time Frame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients ] [ Designated as safety issue: No ]
  • dose and usage of hormones(only for severe pandemic H1N1 influenza patients) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Inflammation of lung tissue(only for severe pandemic H1N1 influenza patients) [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 1100
Study Start Date: January 2010
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chinese herbal medicines plus western therapy Drug: Chinese herbal medicines plus western therapy
injections of Chinese herbal medicines and Chinese herbal medicines decoction& supportive therapy and antivirus therapy when necessary
Active Comparator: western therapy
including supportive therapy and antivirus therapy when necessary
Drug: western therapy
supportive therapy and antivirus therapy when necessary

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of severe pandemic H1N1 influenza patients and pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza
  • Rapid Diagnostic Tests:positive
  • Age≥6 years
  • Influenza symptoms occurred less than 48 hours and body temperature≥37.5℃ for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza

Exclusion Criteria:

  • Suffering from mental illness
  • Attending other clinical studies on influenza
  • Critical pandemic H1N1 influenza patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053533

Locations
China, Beijing
Mao Yu Recruiting
Beijing, Beijing, China, 100015
Contact: Yu Mao       myqmz58@yahoo.com   
Contact: Guang Yu Wang       influenzatcm@163.com   
Principal Investigator: Guang YU Wang         
Sponsors and Collaborators
Beijing Ditan Hospital
Beijing University of Chinese Medicine
State Administration of Traditional Chinese Medicine of the People's Republic of China
China Academy of Chinese Medical Sciences
  More Information

No publications provided

Responsible Party: Beijing Di Tan Hospital
ClinicalTrials.gov Identifier: NCT01053533     History of Changes
Other Study ID Numbers: 20100118
Study First Received: January 19, 2010
Last Updated: June 7, 2010
Health Authority: China:Beijing Ditan Hospital's IRB

Keywords provided by Beijing Ditan Hospital:
Chinese herbal medicines
pandemic H1N1 influenza
effectiveness
safety

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 09, 2014